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FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pedia...[ Price : $8.95]
Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drug...[ Price : $8.95]
FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologic...[ Price : $8.95]
FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne...[ Price : $8.95]
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme ...[ Price : $8.95]
FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identifi...[ Price : $8.95]
FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal co...[ Price : $8.95]
FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identi...